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CTRI Number  CTRI/2018/03/012730 [Registered on: 22/03/2018] Trial Registered Retrospectively
Last Modified On: 19/09/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparative study of instilling balloon cuff of breathing tube inserted in the throat during when patient is made unconscious under anaesthesia with 3 different drugs on patients heart rate and blood pressure when reversed form anaesthesia  
Scientific Title of Study   Comaparitive study of extubation response among three groups by instilling intracuff saline, alkalinised lignocaine and alkalinised lignocaine with dexamethasone. A prospective, double blinded randomized control trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Divya Dinakar A  
Designation  Junior resident  
Affiliation  Kasturba hospital Manipal  
Address  Department of anaesthesiology Kasturba Medical College hospital Manipal

Udupi
KARNATAKA
576104
India 
Phone  9739214523  
Fax    
Email  dinakar.divya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Arun Kumar HD 
Designation  Associate professor 
Affiliation  KMC Manipal  
Address  Department of anaesthesiology Kasturba Medical College hospital Manipal

Udupi
KARNATAKA
576104
India 
Phone  9008415858  
Fax    
Email  arunhd2000@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Divya Dinakar A  
Designation  Junior resident  
Affiliation  KMC Manipal  
Address  Department of anaesthesiology Kasturba Medical College hospital Manipal


KARNATAKA
576104
India 
Phone  9739214523  
Fax    
Email  dinakar.divya@gmail.com  
 
Source of Monetary or Material Support  
Guide of PG thesis Dr Arun Kumar HD associate proffesor , department of anaesthesiology Kasturba hospital Manipal: 576104  
 
Primary Sponsor  
Name  PG thesis fund 
Address  KMC Manipal. Udupi - 576104 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Divya Dinakar A  Kasturba hospital manipal  Department of Anaesthesiology, 1st floor, OT block
Udupi
KARNATAKA 		 9739214523

dinakar.divya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  healthy patients scheduled for elective surgery under general anaesthesia ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aklalinised lignocaine 40 mg   2ml of 2 % lignocaine with 2 ml of saline and 1 ml of 8.4% soda bicarbonate. 5 ml instilled in the cuff once at the beginning of surgery. Tube with cuff removed at the end of surgery.  
Intervention  Alkalised lignocaine 40mg with dexamethasone 8mg   2ml of 2 % lignocaine with 2 ml of dexamethasone and 1 ml of 8.4% soda bicarbonate. 5 ml instilled in the cuff once at the beginning of surgery. Tube with cuff removed at the end of surgery.  
Comparator Agent  Normal saline   5 ml instilled in the cuff once at the beginning of surgery. Tube with cuff removed at the end of surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patients undergoing superficial surgery under general anaesthesia requiring endotracheal intubation 
 
ExclusionCriteria 
Details  pregnancy
emergency surgeries
uncontrolled co morbidities
active URTI/LRTI 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Extubation response once the surgery is completeld, starting from after reversal of neuromuscular blockade   Extubation response recorded every 2 minutes after giving reversal till the removal of the tube to a maximum of 15 minutes. 
 
Secondary Outcome  
Outcome  TimePoints 
Bucking of patient   Recorded from the end of surgery every 2 minutes until 10 minutes after shifting patient out of the OT  
Post operative sore throat  Stars from shifting patient out of the OT every 6 hours till 24 hours after surgery 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   08/05/2017 
Date of Study Completion (India) 12/07/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is a randomised control trail to study and compare three methods of instilling the endotracheal tube cuff with 2 drugs vs a control and studying the hemodynamic extubation response that the endotracheal tube cuff has on the  patient. Healthy adults of either gender scheduled to undergo superficial surgery under general anaesthesia requiring endotracheal intubation have been selected for the study after getting written informed consent. No complications secondary to drug instillation in the cuff have been reported in previous studies. Bucking and post operative sore throat are secondary outcomes that are studied. 
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